Arthroplasty Versus Internal Fixation for Undisplaced Femoral Neck Fracture
NCT ID: NCT04075461
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
330 participants
INTERVENTIONAL
2020-02-01
2025-01-26
Brief Summary
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Detailed Description
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Each year, 7,000 patients suffer a hip fracture. This is a severe condition leading to 25% mortality after 1 year and 40% do not recover to the same functional level. Undisplaced FNF is treated with internal fixation in order to aid in fracture healing. However, approximately 10% in Denmark will suffer a reoperation and two RCT's have demonstrated 20-21% reoperations. In comparison, the reoperation frequency was 5-7% for arthroplasty that also demonstrated slightly faster mobilization which is one of the most important factors for decreasing mortality. The hypothesis is therefore that even though arthroplasty is a larger surgery they benefit from the lack of fracture healing, less pain and faster mobilization.
Patients are included in the emergency department and are electronically randomized to either IF or arthroplasty before the surgery. The design is a pragmatic RCT using the implants which are available in the departments. Furthermore, the postoperative treatment protocol is "business as usual" thereby investigating the precise effect of the intervention in real clinical conditions. In addition to a great external validity this allows for easy implemented after study results. The primary outcome is a validated functional score 1 year after surgery and the sample size is calculated to 330 patients. Secondary outcome measures are additional functional assessments and questionnaires, health related quality of life and pain assessment.
We have set up a steering committee consisting of researchers and senior surgeons with a representative from each region. In addition, all but 1 hospital has a representative in project group. The project is therefore anchored in the entire Denmark.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Undisplaced FNF + Arthroplasty
Arthroplasty is the typical surgery for a displaced femoral neck fracture
Arthroplasty
Arthroplasty is commonly used for a displaced femoral neck fracture.
Undisplaced FNF + Internal fixation
Internal fixation is the typical surgery for an undisplaced femoral neck fracture
Internal fixation
Internal fixation is commonly used for undisplaced femoral neck fracture
Interventions
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Arthroplasty
Arthroplasty is commonly used for a displaced femoral neck fracture.
Internal fixation
Internal fixation is commonly used for undisplaced femoral neck fracture
Eligibility Criteria
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Inclusion Criteria
* Undisplaced femoral neck fracture
* Posterior tilt (18) less than 20 degrees
* NMS (13) = 5 and above, indicating an ability to walk
* Cognitive intact in order to achieve informed consent
Exclusion Criteria
* The patient does not speak Danish
65 Years
ALL
No
Sponsors
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Aalborg University Hospital
OTHER
Regionshospital Nordjylland
OTHER_GOV
Aarhus University Hospital
OTHER
Odense University Hospital
OTHER
Slagelse Hospital
OTHER
Bispebjerg Hospital
OTHER
Regionshospitalet Viborg, Skive
OTHER
Randers Regional Hospital
OTHER
Regionshospitalet Horsens
OTHER
Hospital of Southern Jutland
OTHER
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Hvidovre University Hospital
OTHER
Herlev Hospital
OTHER
Hillerod Hospital, Denmark
OTHER
Holbaek Sygehus
OTHER
Zealand University Hospital
OTHER
Sygehus Lillebaelt
OTHER
Nykøbing Falster County Hospital
OTHER
Regional Hospital West Jutland
OTHER
Bornholm Hospital
UNKNOWN
University of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Bjarke Viberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopaedic Surgery and Traumatology, Lillebaelt Hospital
Ole Brink, MD, PhD
Role: STUDY_CHAIR
Department of Orthopaedic Surgery and Traumatology, Aarhus University Hospital
Søren Kold, Professor
Role: STUDY_CHAIR
Department of Orthopaedic Surgery and Traumatology, Aalborg University Hospital
Morten S Larsen, MD
Role: STUDY_CHAIR
Odense University Hospital
Kristoffer B Hare, MD, PhD
Role: STUDY_CHAIR
Department of Orthopaedic Surgery and Traumatology, Slagelse Hospital
Henrik Palm, MD, DmSc
Role: STUDY_CHAIR
Department of Orthopaedic Surgery and Traumatology, Bispebjerg Hospital
Locations
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Hospital of Southern Jutland
Aabenraa, , Denmark
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Herlev Hospital
Copenhagen, , Denmark
Hvidovre Hospital
Copenhagen, , Denmark
Regional Hospital West Jutland
Gødstrup, , Denmark
Hospital of North Zealand
Hillerød, , Denmark
North Denmark Regional Hospital
Hjørring, , Denmark
Holbæk Hospital
Holbæk, , Denmark
Randers Regional Hospital
Horsens, , Denmark
Lillebaelt Hospital
Kolding, , Denmark
Zealand University Hospital
Køge, , Denmark
Nykøbing Falster Hospital
Nykøbing Falster, , Denmark
Odense University Hospital
Odense, , Denmark
Randers Regional Hospital
Randers, , Denmark
Bornholm Hospital
Rønne, , Denmark
Slagelse Hospital
Slagelse, , Denmark
Viborg Regional Hospital
Viborg, , Denmark
Countries
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References
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National Institute for Health and Care Excellence. Hip fracture: mangement. Clinical guideline [CG124]. National Institute for Health and Care Excellence; 2011, updated 2017.
Roberts KC, Brox WT, Jevsevar DS, Sevarino K. Management of hip fractures in the elderly. J Am Acad Orthop Surg. 2015 Feb;23(2):131-7. doi: 10.5435/JAAOS-D-14-00432.
Lu Q, Tang G, Zhao X, Guo S, Cai B, Li Q. Hemiarthroplasty versus internal fixation in super-aged patients with undisplaced femoral neck fractures: a 5-year follow-up of randomized controlled trial. Arch Orthop Trauma Surg. 2017 Jan;137(1):27-35. doi: 10.1007/s00402-016-2591-9. Epub 2016 Nov 11.
Dolatowski FC, Frihagen F, Bartels S, Opland V, Saltyte Benth J, Talsnes O, Hoelsbrekken SE, Utvag SE. Screw Fixation Versus Hemiarthroplasty for Nondisplaced Femoral Neck Fractures in Elderly Patients: A Multicenter Randomized Controlled Trial. J Bone Joint Surg Am. 2019 Jan 16;101(2):136-144. doi: 10.2106/JBJS.18.00316.
Wamper KE, Sierevelt IN, Poolman RW, Bhandari M, Haverkamp D. The Harris hip score: Do ceiling effects limit its usefulness in orthopedics? Acta Orthop. 2010 Dec;81(6):703-7. doi: 10.3109/17453674.2010.537808.
Gjertsen JE, Fevang JM, Matre K, Vinje T, Engesaeter LB. Clinical outcome after undisplaced femoral neck fractures. Acta Orthop. 2011 Jun;82(3):268-74. doi: 10.3109/17453674.2011.588857.
Zlowodzki M, Brink O, Switzer J, Wingerter S, Woodall J Jr, Petrisor BA, Kregor PJ, Bruinsma DR, Bhandari M. The effect of shortening and varus collapse of the femoral neck on function after fixation of intracapsular fracture of the hip: a multi-centre cohort study. J Bone Joint Surg Br. 2008 Nov;90(11):1487-94. doi: 10.1302/0301-620X.90B11.20582.
Sikand M, Wenn R, Moran CG. Mortality following surgery for undisplaced intracapsular hip fractures. Injury. 2004 Oct;35(10):1015-9. doi: 10.1016/j.injury.2004.01.004.
Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.
Kristensen PK, Thillemann TM, Soballe K, Johnsen SP. Are process performance measures associated with clinical outcomes among patients with hip fractures? A population-based cohort study. Int J Qual Health Care. 2016 Dec 1;28(6):698-708. doi: 10.1093/intqhc/mzw093.
de Morton NA, Harding KE, Taylor NF, Harrison G. Validity of the de Morton Mobility Index (DEMMI) for measuring the mobility of patients with hip fracture during rehabilitation. Disabil Rehabil. 2013 Feb;35(4):325-33. doi: 10.3109/09638288.2012.705220. Epub 2012 Aug 16.
de Morton NA, Berlowitz DJ, Keating JL. A systematic review of mobility instruments and their measurement properties for older acute medical patients. Health Qual Life Outcomes. 2008 Jun 5;6:44. doi: 10.1186/1477-7525-6-44.
Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993 Sep;75(5):797-8. doi: 10.1302/0301-620X.75B5.8376443.
Kristensen MT, Foss NB, Kehlet H. [Timed Up and Go and New Mobility Score as predictors of function six months after hip fracture]. Ugeskr Laeger. 2005 Aug 29;167(35):3297-300. Danish.
Kristensen MT, Bandholm T, Foss NB, Ekdahl C, Kehlet H. High inter-tester reliability of the new mobility score in patients with hip fracture. J Rehabil Med. 2008 Jul;40(7):589-91. doi: 10.2340/16501977-0217.
Pedersen TJ, Lauritsen JM. Routine functional assessment for hip fracture patients. Acta Orthop. 2016 Aug;87(4):374-9. doi: 10.1080/17453674.2016.1197534. Epub 2016 Jun 22.
Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.
Palm H, Gosvig K, Krasheninnikoff M, Jacobsen S, Gebuhr P. A new measurement for posterior tilt predicts reoperation in undisplaced femoral neck fractures: 113 consecutive patients treated by internal fixation and followed for 1 year. Acta Orthop. 2009 Jun;80(3):303-7. doi: 10.3109/17453670902967281.
Schmidt M, Pedersen L, Sorensen HT. The Danish Civil Registration System as a tool in epidemiology. Eur J Epidemiol. 2014 Aug;29(8):541-9. doi: 10.1007/s10654-014-9930-3. Epub 2014 Jun 26.
Kristensen MT. Hip fractures - Functional assessments and factors influencing in-hospital outcome, a physiotherapeutic perspective. Faculty of Medicine: Lund University; 2010.
Steihaug OM, Gjesdal CG, Bogen B, Kristoffersen MH, Lien G, Hufthammer KO, Ranhoff AH. Does sarcopenia predict change in mobility after hip fracture? a multicenter observational study with one-year follow-up. BMC Geriatr. 2018 Mar 5;18(1):65. doi: 10.1186/s12877-018-0755-x.
The Danish Interdisciplinary Registry for Hip Fracture. National Annual Report for 2017. The Danish Healthcare Service; 2017 15.05.2017.
Viberg B, Kold S, Brink O, Larsen MS, Hare KB, Palm H; SENSE collaborators. Is arthroplaSty bEtter than interNal fixation for undiSplaced femoral nEck fracture? A national pragmatic RCT: the SENSE trial. BMJ Open. 2020 Oct 10;10(10):e038442. doi: 10.1136/bmjopen-2020-038442.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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S-20180036
Identifier Type: -
Identifier Source: org_study_id
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